FDA.reportPublic FDA data

Pressure Therapy System

Primary DI
06952075702973
Brand
Pressure Therapy System
Company
XIAMEN SENYANG CO.,LTD
Model
PT1002
Device description
Indications for Use:The device is indicated for use by medical professionals and patient at home, who are under medicalsupervision, in treating many conditions, such as: Primary lymph edema, edema following trauma andsport injures, Post immobilization edema, Venous insufficiencies, Lymph edema.Device Description:The system consists of an air pump, leg sleeves and hoses working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; one sleeve has 4 compression chambers. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. This software is to control the timing and the pressure reflected by the sensor, it cycles the airflow to reach the function of cycling compression of body parts.
Published
2026-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161907000Pressure Therapy SystemXiamen Senyang Co., Ltd.2017-02-23IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06952075702973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952075702973069520757029736952075702973

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528175766
Device count
1
Lot or batch
true
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050289252HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
06959557201382Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-15
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.IRP2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.IRP2026-10-12
06976331781397AnacondafightwearHuizhou XINYI Technology Co., LTDIRP2026-10-12
06959557201375Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-10
06959557200286Powered Inflatable Tube MassagerSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-09-30
06974000130033HealthpalXiamen Healthpal Electronic Co., Ltd.IRP2026-08-26
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00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
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00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.IRP2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.IRP2026-07-31